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FDA 510(k)

Reusable and Disposable SpO2 Sensors

K-Number: K201360 · 2020-08-19

Decision Date2020-08-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable and Disposable SpO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Xinkang Medical Instrument Co. , Ltd.. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K201360. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reusable and Disposable SpO2 Sensors?

Reusable and Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Xinkang Medical Instrument Co. , Ltd.. The 510(k) number is K201360.

When did Reusable and Disposable SpO2 Sensors receive FDA 510(k) clearance?

Reusable and Disposable SpO2 Sensors received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201360.

Who is the listed applicant for Reusable and Disposable SpO2 Sensors?

The FDA 510(k) record lists Xinkang Medical Instrument Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable and Disposable SpO2 Sensors?

The FDA product code for Reusable and Disposable SpO2 Sensors is DQA.

Other records listing Xinkang Medical Instrument Co. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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